Preliminary data from a systematic review supported the biosimilarity and interchangeability of biosimilar and reference tumor necrosis factor alpha (TNF-α) inhibitors.
Study authors from Johns Hopkins Bloomberg School of Public Health and Brigham and Women’s Hospital summarized the data regarding the bioequivalence between biosimilar and reference TNF-α inhibitors. They searched various databases through April 30, 2016 for any studies that compared the pharmacokinetics, clinical efficacy, adverse events, or immunogenicity of a biosimilar TNF-α inhibitor with a reference biologic in human subjects.
A total of 19 studies were eligible, 8 of which were Phase 1 randomized trials, 5 of which were Phase 3 randomized trials, and 6 of which were observational studies. The Phase 1 trials demonstrated that pharmacokinetic parameters of the biosimilar and respective biologic were within the prespecified equivalence margin of 80–125%.
Data from the Phase 3 trials suggested similar clinical responses and adverse events; the adverse events were usually of mild to moderate severity. Two observational studies showed cross-reactivity between products, whereas 4 cohort studies of patients switched from reference to biosimilar products indicated similar efficacy and safety outcomes.
The researchers cited possible publication bias, small sample size, and lack of published studies for several biosimilars as limitations to the review. Overall, these initial findings support the biosimilarity and interchangeability of the compared agents.
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